BEUDAMED
    FDA Adverse Event Summary report: N

    ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICE

    MDR report key: 4356196 · Received December 12, 2014

    Report

    Report Number
    1528319-2014-00029
    Date Received
    December 12, 2014
    Date of Event
    November 18, 2013
    Report Date
    December 12, 2014
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    KOG
    PMA / PMN Number
    K040494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAPSULE HOLDER AND BASE ASSEMBLY IS USED TO PARTIALLY ENCAPSULATE THE VIDEO CAPSULE. THE ASSEMBLY IS FLEXIBLE AND CLOSELY FITTED TO THE SHAPE OF THE VIDEO CAPSULE. THE ASSEMBLY HAS ATRAUMATIC FEATURES INCLUDING A ROUNDED PERIMETER AND SIDE SLOTS. THE DEVICE WAS NOT RETURNED FOR EXAMINATION. REVIEW OF THE LOT HISTORY RECORD ((B)(4) LOT 1315787, MANUFACTURED JUNE 2013, 50 BX) INDICATES NO ANOMALIES IN THE MANUFACTURE OF THE LOT. A REVIEW OF COMPLAINT HISTORY FINDS NO OTHER COMPLAINTS ASSOCIATED WITH (B)(4) LOT 1315787.

    Description of Event or Problem · 1

    THE DEVICE IS USED IN THE TRANSENDOSCOPIC DELIVERY OF THE GIVEN PILLCAM SB VIDEO CAPSULE TO THE STOMACH OR DUODENUM IN PATIENTS WHO ARE EITHER UNABLE TO SWALLOW THE VIDEO CAPSULE, OR UNABLE TO PASS THE VIDEO CAPSULE BEYOND THE PYLORUS IN SUFFICIENT TIME TO COMPLETE THE DESIRED DIAGNOSTIC EVALUATION. A CUSTOMER REPORTED THE CAPSULE HOLDER SEPARATED FROM THE CAPSULE BASE DURING PROCEDURAL USE, CAUSING THE CAPSULE HOLDER TO DEPLOY WITH THE VIDEO CAPSULE. NO HARM WAS REPORTED TO THE PATIENT OR THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815890 ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICE CAPSULE DELIVERY DEVICDE KOG UNITED STATES ENDOSCOPY GROUP, INC. 00711144 1315787

    Patients

    Seq Age Sex Outcome Treatment
    1